BSD Medical (BSDM) Announces Conclusion of FDA Pre-approval Audit for BSD-2000 PMA Submission
8/23/2007 7:31:59 AM
SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corp. (AMEX: BSM) today announced the completion of the Food and Drug Administration’s (FDA) pre-approval audit for the PMA submission of the company’s BSD-2000 hyperthermia system, along with the completion of a routine Quality System (QA)/Good Manufacturing Practices (GMP) inspection. FDA did not provide any written inspectional deficiencies (Form 483) at the conclusion of the on-site inspection. The completion of the preapproval FDA inspection is a significant milestone in the PMA approval process for a medical device. The FDA’s review of the company’s PMA submission is ongoing.